Ulnar compression device

ABSTRACT

In some examples, a tissue compression device includes a base including a major surface configured to engage a dorsal surface of a hand of a patient, a flexible backing adjustably mechanically connected to the base and configured to engage a palmar surface of the hand when the dorsal surface of the hand is engaged with the base, and an expandable member mechanically connected to the flexible backing. The expandable member is configured to be positioned over an ulnar region of the patient when the palmar surface of the hand is engaged with the flexible backing and the dorsal surface of the hand is engaged with the base, such that inflation of the expandable member may apply pressure to tissue near the ulnar artery of the patient.

This application claims the benefit of U.S. Provisional Application Ser.No. 62/714,865, entitled “DISTAL RADIAL COMPRESSION DEVICE,” and filedon Aug. 6, 2018, and claims the benefit of U.S. Provisional ApplicationSer. No. 62/736,241, entitled “ULNAR COMPRESSION DEVICE,” and filed onSep. 25, 2018, the entire content of each of which is incorporatedherein by reference.

TECHNICAL FIELD

This disclosure relates to tissue compression devices.

BACKGROUND

Medical catheters may be advanced through an access site intovasculature of a patient to provide a lumen through which medicaldevices or therapeutic agents may be introduced to reach a treatmentsite. For example, the access site for percutaneous coronary proceduresmay include the radial artery or the femoral artery of a patient.

SUMMARY

The present disclosure describes tissue compression devices andtechniques to apply pressure to an ulnar region of a patient before,during, and/or after a transradial access procedure. The ulnar regionmay include tissue at or near (e.g., superficial to) an ulnar arteryand/or ulnar veins in an arm of the patient. Application of pressure atthe ulnar region may be used to facilitate transradial access, reduceocclusion of the radial artery after transradial procedure, or both. Insome examples, a tissue compression device includes a base including amajor surface configured to engage a dorsal surface of a hand of apatient; a flexible backing configured to be adjustably mechanicallyconnected to the base and configured to engage a palmar surface of thehand when the dorsal surface of the hand is engaged with the base; andan expandable member mechanically connected to the flexible backing. Theexpandable member is configured to be positioned over an ulnar region ofthe patient when the palmar surface of the hand is engaged with theflexible backing and the dorsal surface of the hand is engaged with thebase. The expandable member also is configured to apply pressure to theulnar region before, during, and/or after a transradial accessprocedure.

In other examples, a tissue compression device has a band-likeconfiguration (e.g., a bracelet-like configuration) and includes a firstexpandable member configured to be positioned over (e.g., superficialto) an ulnar region of the patient and a second expandable memberconfigured to be positioned over an radial artery of the patient whenthe device is positioned on an arm of a patient.

Clause 1: In some examples, a tissue compression device comprises a basecomprising a major surface configured to engage a dorsal surface of ahand of a patient; a flexible backing adjustably mechanically connectedto the base and configured to engage a palmar surface of the hand whenthe dorsal surface of the hand is engaged with the base; and anexpandable member mechanically connected to the flexible backing, theexpandable member configured to be positioned over an ulnar region ofthe patient when the palmar surface of the hand is engaged with theflexible backing and the dorsal surface of the hand is engaged with thebase, and the expandable member configured to apply pressure to theulnar region.

Clause 2: In some examples, a tissue compression device comprises arigid base comprising a major surface configured to engage a dorsalsurface of a hand of a patient; a radial lip extending from the majorsurface and configured to engage a radial border of the hand when thedorsal surface of the hand is engaged with the base; and a ulnar lipextending from the major surface and configured to engage an ulnarborder of the hand when the dorsal surface of the hand is engaged withthe base; an inextensible flexible backing adjustably mechanicallyconnected to the base and configured to engage a palmar surface of thehand to urge the dorsal surface of the hand toward the major surface ofthe base; and an expandable member mechanically connected to theflexible backing, the expandable member configured to be positioned overan ulnar region of the patient when the palmar surface of the hand isengaged with the flexible backing and the dorsal surface of the hand isengaged with the base, and the expandable member configured to inflateto increase the volume of the expandable member.

Clause 3: In some examples of the tissue compression device of clause 1or clause 2, the expandable member comprises a bladder configure toinflate to at least a pressure to cause compression of tissue near anulnar artery of the patient.

Clause 4: In some examples of the tissue compression device of any oneof clauses 1 through 3, the base comprises a plurality of baseattachment structures, the flexible backing comprises a plurality ofbacking attachment structures, and each backing attachment structure ofthe plurality of backing attachment structures is configured toadjustably mechanically connect the flexible backing to a respectivebase attachment structure of the plurality of base attachmentstructures.

Clause 5: In some examples of the tissue compression device of clause 4,at least one backing attachment structure of the plurality of backingattachment structures is configured to adjust a tension of the flexiblebacking to urge the dorsal surface of the hand of the patient toward themajor surface of the base when the palmar surface of the hand is engagedwith the flexible backing.

Clause 6: In some examples of the tissue compression device of any oneof clauses 1 through 5, the expandable member is removably mechanicallyconnected to the flexible backing.

Clause 7: In some examples of the tissue compression device of any oneof clauses 1 through 5, the expandable member is integrally formed withthe flexible backing.

Clause 8: In some examples of the tissue compression device of any oneof clauses 1 through 7, the flexible backing comprises a substantiallyinextensible material.

Clause 9: In some examples of the tissue compression device of any oneof clauses 1 through 8, at least one of the base or the flexible backingis configured to engage a left hand of the patient, a right hand of thepatient, or both the left hand and the right hand of the patient.

Clause 10: In some examples of the tissue compression device of any oneof clauses 1 through 9, the base comprises a substantially rigidthermoplastic or a substantially rigid thermoset plastic.

Clause 11: In some examples of the tissue compression device of any oneof clauses 1 through 9, the base is configured to reduce a range ofmotion of a digit of the hand or a portion of a wrist of the patientwhen the dorsal surface of the hand is engaged with the first majorsurface of the base.

Clause 12: In some examples of the tissue compression device of any oneof clauses 1 through 11, the base comprises a first lip extending fromthe major surface and configured to engage an ulnar border of the handwhen the dorsal surface of the hand is engaged with the base; and asecond lip extending from the major surface and configured to engage aradial border of the hand when the dorsal surface of the hand is engagedwith the base.

Clause 13: In some examples of the tissue compression device of any oneof clauses 1 through 12, the base is configured to position the hand ofthe patient in a predetermined configuration when the dorsal surface ofthe hand is engaged with the major surface of the base.

Clause 14: In some examples of the tissue compression device of any oneof clauses 1 through 13, the expandable member comprises a firstexpandable member, and the tissue compression device further comprises asecond expandable member mechanically connected to the flexible backing,the second expandable member configured to be positioned over a radialregion of the patient when the palmar surface of the hand is engagedwith the flexible backing and the dorsal surface of the hand is engagedwith the base, the second expandable member being configured to applypressure to the radial region.

Clause 15: In some examples of the tissue compression device of clause14, the second expandable member comprises a bladder configure toinflate to at least a pressure to cause patent hemostasis of a vascularaccess site at the radial artery of the patient.

Clause 16: In some examples of the tissue compression device of clause14 or 15, the second expandable member is configured to be detached andsubsequently reattached to the flexible backing.

Clause 17: In some examples, a method includes mechanically connecting aflexible backing of a tissue compression device to a first baseattachment structure of a plurality of base attachment structuresdefined by or extending from a major surface of a base of the tissuecompression device, the major surface configured to engage a dorsalsurface of a hand of a patient; and mechanically connecting the flexiblebacking to a second base attachment structure of the plurality of baseattachment structures, the flexible backing configured to be adjustablymechanically connected to the base, the tissue compression devicefurther comprising an expandable member mechanically connected to theflexible backing, the expandable member configured to be positioned overan ulnar region of the patient when the dorsal surface of the hand isengaged with the major surface of the base, the expandable memberconfigured to apply pressure to tissue near an ulnar artery of thepatient.

Clause 18: In some examples of the method of clause 17, the methodfurther comprises positioning the dorsal surface of the hand of thepatient on the major surface of the base.

Clause 19: In some examples of the method of clause 18, positioning thedorsal surface of the hand on the major surface of the base comprisespositioning the dorsal surface of the hand on the major surface of thebase prior to mechanically connecting the flexible backing to the secondbase attachment structure.

Clause 20: In some examples of the method of clause 18, positioning thedorsal surface of the hand on the major surface of the base comprisespositioning the dorsal surface of the hand on the major surface of thebase after mechanically connecting the flexible backing to the secondbase attachment structure.

Clause 21: In some examples of the method of any one of clauses 18through 20, the method further comprises, after positioning the dorsalsurface of the hand of the patient on the major surface of the base,inflating the expandable member to cause compression of tissue near theulnar artery.

Clause 22: In some examples of the method of any one of clauses 18through 21, the method further comprises, after positioning the dorsalsurface of the hand of the patient on the major surface of the base,adjusting a position of the expandable member relative to the hand ofthe patient.

Clause 23: In some examples of the method of clause 22, adjusting theposition of the expandable member relative to the hand of the patientcomprises loosening or tightening a mechanical connection between theflexible backing and at least one of the first or second base attachmentstructures.

Clause 24: In some examples of the method of clause 22, adjusting theposition of the expandable member relative to the hand of the patientcomprises detaching the expandable member from the flexible backing andsubsequently reattaching the expandable member to the flexible backing.

Clause 25: In some examples of the method of any one of clauses 17through 24, the flexible backing comprises a plurality of backingattachment structures, and mechanically connecting the flexible backingto the first base attachment structure comprises adjustably mechanicallyconnecting a first backing attachment structure of the plurality ofbacking attachment structures to the first base attachment structure,and mechanically connecting the flexible backing to the second baseattachment structure comprises adjustably mechanically connecting asecond backing attachment structure of the plurality of backingattachment structures to the second base attachment structure.

Clause 26: In some examples of the method of any one of clauses 17through 25, at least one base attachment structure of the plurality ofbase attachment structures is integrally formed with the major surface.

Clause 27: In some examples of the method of any one of clauses 17through 25, at least one base attachment structure of the plurality ofbase attachment structures is physically separate from the majorsurface, and the method further comprises, before mechanicallyconnecting the flexible backing to the first base attachment structure,attaching the at least one base attachment structure of the plurality ofbase attachment structures to the major surface.

Clause 28: In some examples of the method of any one of clauses 17through 27, the base comprises a first lip extending from the majorsurface and configured to engage an ulnar border of the hand when thedorsal surface of the hand is engaged with the base; and a second lipextending from the major surface and configured to engage a radialborder of the hand when the dorsal surface of the hand is engaged withthe base.

Clause 29: In some examples of the method of any one of clauses 17through 28, the expandable member is integrally formed with the flexiblebacking.

Clause 30: In some examples of the method of any one of clauses 17through 29, the flexible backing comprises a substantially inextensiblematerial.

Clause 31: In some examples of the method of any one of clauses 17through 30, the base is configured to reduce a range of motion of adigit of the hand or a portion of a wrist of the patient when the dorsalsurface of the hand is engaged with the major surface of the base.

Clause 32: In some examples of the method of any one of clauses 17through 31, the base is configured to position the hand of the patientin a predetermined configuration when the dorsal surface of the hand isengaged with the major surface of the base.

Clause 33: In some examples of the method of any one of clauses 17through 32, the method further comprises forming the base from asubstantially rigid thermoplastic or a substantially rigid thermosetplastic.

Clause 34: In some examples of the method of any one of clauses 17through 33, the method further comprises cutting the flexible backingfrom a substantially inextensible material.

Clause 35: In some examples of the method of any one of clauses 17through 34, the method further comprises attaching the expandable memberto the flexible backing by at least one of adhering, welding, ormechanically fastening the expandable member to the flexible backing.

Clause 36: In some examples of the method of any one of clauses 17through 35, the expandable member comprises a first expandable memberand the tissue compression device further comprises a second expandablemember mechanically connected to the flexible backing, and the methodfurther comprises, after positioning the dorsal surface of the hand ofthe patient on the major surface of the base, adjusting a position ofthe second expandable member to position the second expandable memberover a radial artery of the patient.

Clause 37: In some examples of the method of clause 36, the methodfurther comprises, after adjusting a position of the second expandablemember, inflating the second expandable member to apply pressure to aradial artery of the patient to cause patent hemostasis of a vascularaccess site at the radial artery.

Clause 38: In some examples of the method of any one of clauses 17through 35, the tissue compression device further comprises a secondexpandable member mechanically connected to the flexible backing, andthe method further comprises, after positioning the dorsal surface ofthe hand of the patient on the major surface of the base, inflating thesecond expandable member to apply pressure to a radial artery of thepatient to cause patent hemostasis of a vascular access site at theradial artery.

Clause 39: In some examples, a tissue compression device comprises aband configured to engage a wrist of a patient; a first expandablemember mechanically connected to the band, the first expandable memberbeing configured to be positioned over an ulnar region of the patientwhen the band is engaged with the wrist of the patient, the firstexpandable member being configured to apply pressure to the ulnarregion; and a second expandable member mechanically connected to theband, the second expandable member being configured to be positionedover a radial region of the patient when the band is engaged with thewrist of the patient, and the second expandable member being configuredto apply pressure to the radial region.

Clause 40: In some examples of the tissue compression device of clause39, the band comprises a base comprising a major surface configured toengage a first portion of the wrist of the patient; and a flexiblebacking adjustably mechanically connected to the base and configured toengage a second portion of the wrist of the patient, the firstexpandable member is mechanically connected to at least one of the baseor the flexible backing, and the second expandable member ismechanically connected to at least one of the base or the flexiblebacking.

Clause 41: In some examples of the tissue compression device of clause39 or 40, the first expandable member comprises a first bladderconfigured to inflate to at least a pressure to cause compression oftissue near an ulnar artery of the patient, and the second expandablemember comprises a second bladder configure to inflate to at least apressure to cause patent hemostasis of a vascular access site at theradial artery of the patient.

Clause 42: In some examples of the tissue compression device of any oneof clauses 40 through 41, the base comprises at least one baseattachment structure, the flexible backing comprises at least onebacking attachment structure, and the at least one backing attachmentstructure is configured to adjustably mechanically connect the flexiblebacking to the at least one base attachment structure.

Clause 43: In some examples of the tissue compression device of clause42, the at least one backing attachment structure is configured toadjust a tension of the flexible backing to urge at least one of thefirst expandable member or the second expandable member toward the wristof the patient when the wrist of the patient is engaged with the band.

Clause 44: In some examples of the tissue compression device of any oneof clauses 39 through 43, at least one of the first expandable member orthe second expandable member is removably mechanically connected to theband.

Clause 45: In some examples of the tissue compression device of any oneof clauses 39 through 43, at least one of the first expandable member orthe second expandable member is integrally formed with the band.

Clause 46: In some examples of the tissue compression device of any oneof clauses 40 through 45, the flexible backing comprises a substantiallyinextensible material.

Clause 47: In some examples of the tissue compression device of any oneof clauses 39 through 46, the band is configured to engage a left wristof the patient, a right wrist of the patient, or both the left wrist andthe right wrist of the patient.

Clause 48: In some examples of the tissue compression device of any oneof clauses 40 through 47, the base comprises a substantially rigidthermoplastic or a substantially rigid thermoset plastic.

Clause 49: In some examples of the tissue compression device of any oneof clauses 40 through 48, the base is shaped to correspond to ananatomical shape of at least part of the wrist of the patient.

Clause 50: In some examples of the tissue compression device of any oneof clauses 40 through 49, the base and the flexible backing areintegrally formed.

Clause 51: In some examples, a method includes using the tissuecompression device of any one of clauses 39 through 50.

Clause 52: In some examples, a method includes forming the tissuecompression device of any one of clauses 39 through 50.

The details of one or more examples are set forth in the accompanyingdrawings and the description below. Other features, objects, andadvantages will be apparent from the description and drawings, and fromthe claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1A is a conceptual perspective view of an example tissuecompression device including a flexible backing adjustably mechanicallyconnected to a base and an expandable member mechanically connected tothe flexible backing.

FIG. 1B is a conceptual perspective view of the base of the exampletissue compression device illustrated in FIG. 1A.

FIG. 2 is a conceptual perspective view illustrating the example tissuecompression device of FIG. 1A retained on a hand of a patient.

FIGS. 3A and 3B are conceptual side views in the Y-Z and X-Z planes,respectively, illustrating the example tissue compression device of FIG.1A.

FIG. 4 is a conceptual perspective view illustrating an example tissuecompression device including at least two expandable members.

FIGS. 5A and 5B are conceptual plan and side views illustrating anexample tissue compression device having a band-type configurationincluding at least two expandable members.

FIG. 6 is a flow diagram illustrating an example method of assembling atissue compression device including a flexible backing adjustablymechanically connected to a base and an expandable member mechanicallyconnected to the flexible backing.

FIG. 7 is a flow diagram illustrating an example method of using atissue compression device including a flexible backing adjustablymechanically connected to a base and an expandable member mechanicallyconnected to the flexible backing.

DETAILED DESCRIPTION

Percutaneous coronary procedures with transradial access may result inradial artery occlusion (e.g., acute and/or chronic radial arteryocclusion). Radial artery occlusion may be caused by acute thrombosisdue to intimal abrasion and vessel injury in conjunction with blood flowcessation when pressure is applied to the radial artery access site(e.g., radial compression) to achieve hemostasis. Radial arteryocclusion may be undesirable. For example, radial artery occlusion maylimit future ipsilateral transradial access, cause transient discomfortto the patient, or any combination thereof.

The disclosure describes tissue compression devices configured to applypressure to an ulnar region of a patient, as well as techniques forforming and using the tissue compression devices. Example tissuecompression devices described herein are configured to apply pressure totissue at the ulnar region to compress the ulnar artery, the ulnar vein,or both and may include a base, a flexible backing adjustablymechanically connected to the base, and an expandable membermechanically connected to the flexible backing. The ulnar region mayinclude selected tissue near (e.g., superficial to) an ulnar arteryand/or an ulnar vein of the patient. In some examples, the base and theflexible backing are configured to engage the hand of the patient (e.g.,at least one of the hand, the wrist, and the forearm of the patient) toposition the expandable member over the ulnar region proximal the handof the patient. By engaging the hand of the patient, the tissuecompression device may reduce movement of the expandable member relativeto the ulnar region, which may enable the tissue compression device tomore consistently apply pressure to the ulnar region.

The tissue compression device is configured to apply pressure toselected tissue beneath the expandable member, e.g., to tissue thattransmits the pressure to the ulnar artery or ulnar vein. It is believedthat ipsilateral ulnar artery compression (also referred to as ulnarcompression) may maintain or increase radial artery blood flow duringradial compression to reduce incidence of radial artery occlusioncompared to other methods alone, such as compared to the use of a lowsheath (part of the percutaneous access device) to artery size ratio,the use of intraprocedural heparin, or the maintenance of radial arterypatency during hemostasis after transradial access. Ulnar compressionmay result in complete or near complete occlusion of the ulnar artery toincrease blood flow in the radial artery. The increased blood flow inthe radial artery may enable compression of the radial artery with apressure sufficient to achieve hemostasis at the transradial access sitewithout causing radial artery occlusion. In this way, the disclosedtissue compression device may reduce incidence of radial arteryocclusion and improve the healing process after percutaneous coronaryprocedures with transradial access compared to other methods.

Additionally, it is believed that ulnar artery compression may improvethe outcomes or ease of transradial percutaneous coronary procedures byfacilitating access to the vasculature of the patient. For example, aweak radial pulse due to a relatively small radial artery, a relativelydeep radial artery, or hypotension may make vasculature access byarteriotomy of the radial artery difficult. It is believed that ulnarcompression may be used to improve accuracy and speed of vasculatureaccess via arteriotomy of the radial artery by making radial pulsestronger and/or enlarging the radial artery to improve success rate offingertip palpitation-guided access to the radial artery.

FIG. 1A is a conceptual perspective view illustrating an example tissuecompression device 10 including a base 12, a flexible backing 14adjustably mechanically connected to base 12, and an expandable member16 mechanically connected to flexible backing 14. Tissue compressiondevice 10 may be configured to receive and engage a hand of a patient toapply pressure to selected tissue at the ulnar region (e.g., alignedwith but superficial to the ulnar artery and/or ulnar vein) of thepatient to thereby apply pressure to the ulnar artery and/or ulnar vein.The selected tissue may be proximal the wrist of the patient, such asimmediately proximal the wrist or a greater distance proximal to thewrist (e.g., between about 1 centimeter and about 15 centimetersproximal to the wrist), distal the wrist, such as on a portion of thehand of the patient, or on the wrist.

FIG. 1B is a conceptual perspective view of base 12 of tissuecompression device 10 illustrated in FIG. 1A. FIG. 1B illustrates tissuecompression device 10 without flexible backing 14. Base 12 defines afirst major surface 20 and a second major surface 22 (not visible inFIGS. 1A and 1B, shown in FIG. 3) on an opposite side of base 12 fromfirst major surface 20. First major surface 20 and second major surface22 face in different directions. First major surface 20 may include anysuitable shape configured to engage with at least a portion of the hand,wrist, and/or forearm of the patient. For example, as illustrated inFIGS. 1A and 1B, first major surface 20 may have a shape in the X-Yplane (orthogonal X-Y-Z axes are shown in the figures for ease ofdescription only) that corresponds to an anatomical shape of at leastpart of a right hand or a left hand of a patient (e.g., mimics thegeneral outline of the footprint of a hand or part of the footprint ofthe hand). In some examples, first major surface 20 may have a shape inthe X-Y plane that corresponds to an anatomical shape of both the righthand and the left hand of the patient, e.g., first major surface 20 maybe ambidextrous. In other examples, first major surface 20 may haveother shapes, such as elliptical, rectangular, or irregular shapes.

In some examples, second major surface 22 may be shaped the same as orsubstantially similar to first major surface 20, which may permit secondmajor surface 22 to be used to engage the other hand of a patient iffirst major surface 20 is configured to engage with only the left handor the right hand. For example, second major surface 22 may be a mirrorimage of the shape of first major surface 20 such that second majorsurface 22 has a shape that corresponds to an anatomical shape of eitherthe right hand or the left hand of the patient and first major surface20 has a shape that corresponds to an anatomical shape of the other ofthe left hand or the right hand of the patient. In this way, base 12 maybe shaped to engage both the left hand of the patient and the right handof the patient by inverting base 12 to engage the dorsal surface of thehand of the patient with one of the first major surface 20 or secondmajor surface 22.

In some examples, base 12 has a three-dimensional shape configured toposition the hand of the patient in a predetermined configuration orreduce a range of motion of a digit of the hand or a portion of thewrist of the patient when a surface of the hand is positioned over firstmajor surface 20 of base 12. The predetermined configuration mayinclude, for example, a flat (e.g., the hand may sit flat on a planarsurface) or a non-flat hand configuration, a partially bent position ofone or more digits (e.g., fingers or the thumb) or the wrist of thepatient (e.g., a flexed position or a cupped or grasped position), anextended position of one or more digits or the wrist of the patient, ora combination thereof. For example, base 12 may be shaped such thatfirst major surface 20 is shaped to correspond to a shape of a dorsalsurface of the hand of the patient in the predetermined configuration,such that base 12 includes one or more structures configured tocorrespond to the position of one or more digits or the wrist of thepatient in the predetermined configuration, or both.

In some examples, base 12 defines a lip 15 and/or 17, which are eachexample structures configured to help hold the hand of the patient in aparticular configuration or reduce a range of motion of a digit of thehand or a portion of the wrist of the patient when the dorsal surface ofthe hand is engaged with first major surface 20 of base 12. For example,first lip 15 (e.g., ulnar lip) may be configured to engage at least aportion of the ulnar border of the hand of the patient when the dorsalsurface of the hand is engaged with first major surface 20. In someexamples, first lip 15 extends from an ulnar side 19 of base 12 to atleast partially surround the ulnar border of the hand to control (e.g.,limit) at least one of ulnar abduction, palmar flexion, or dorsalflexion of the hand. In some examples, first lip 15 may extend (e.g.,substantially along the X-axis) from a distal end 23 of base 12 to aproximal end 25 of base 12 or any portion thereof. In other examples,first lip 15 includes a plurality of first lips spaced from each otherand extending from two or more portions of ulnar side 19 of base 12. Thelocations of the plurality of first lips may be selected to improvecontrol of at least one of ulnar abduction, palmar flexion, and dorsalflexion of the hand. Control of at least one of ulnar abduction, palmarflexion, and dorsal flexion of the hand using first lip 15 may improvepositioning the hand of the patient in the predetermined configurationand/or may help constrain the hand to hold the hand in the predeterminedconfiguration.

In some examples, base 12 defines a second lip 17 instead of or inaddition to first lip 15. Second lip 17 (e.g., radial lip) may beconfigured to engage at least a portion of the radial border of the handof the patient when the dorsal surface of the hand is engaged with firstmajor surface 20. For example, second lip 17 may extend from base 12 toat least partially surround the radial border of the hand to control(e.g., limit) at least one of radial abduction, palmar flexion, anddorsal flexion of the hand. In some examples, second lip 17 may extendfrom distal end 23 of base 12 to proximal end 25 of base 12 or anyportion thereof. In other examples, second lip 17 includes a pluralityof second lips spaced from each other and extending from two or moreportions of radial side 21 of base 12. The locations of the plurality ofsecond lips may be selected to improve control of at least one of radialabduction, palmar flexion, and dorsal flexion of the hand. Control of atleast one of radial abduction, palmar flexion, and dorsal flexion of thehand using second lip 17 may improve positioning the hand of the patientin the predetermined configuration and/or may help constrain the hand tohold the hand in the predetermined configuration.

By positioning the hand of the patient in a predetermined configuration,base 12 may provide benefits for some medical procedures compared toother compression devices, such as bracelet or band type compressiondevices, which do not position the hand of the patient in apredetermined configuration. For example, positioning the hand of thepatient in a predetermined configuration may improve comfort of thepatient by allowing the hand of the patient to be positioned in anatural configuration while the patient is in a supine position.Additionally, or alternatively, positioning the hand of the patient in apredetermined configuration may present the ulnar artery moreprominently to reduce the pressure required to achieve compression ofthe ulnar artery, the ulnar vein, or both.

In some examples, base 12 is formed from one or more substantially rigidmaterials. A substantially rigid material may include a material havingan apparent modulus of rigidity (e.g., apparent shear modulus ofelasticity) in ambient conditions sufficient to reduce deflection ofbase 12 by the hand of the patient before, during, or after apercutaneous coronary procedure. For example, a substantially rigidmaterial may include a material having an apparent shear modulus of atleast approximately 0.1 gigapascal (GPa). In some examples, base 12includes one or more substantially rigid thermoplastics, such asacrylonitrile butadiene styrene (ABS), polyethylene, polycarbonate,polyamide, high impact polystyrene, polypropylene, or polyoxymethylene;or substantially rigid thermoset plastics, such as polyester,polyurethane, or epoxy resin. Base 12 can be entirely rigid in someexamples, while in in other examples, base 12 may include one or moreflexible regions or joints configured to improve patient comfort whentissue compression device 10 is retained on the hand of the patient.

In the example illustrated in FIGS. 1A and 1B, first major surface 20 isconfigured to face a dorsal surface of the hand of the patient whentissue compression device 10 is retained on the hand of the patient. Insome examples, first major surface 20 may be configured to engage with adorsal surface of the hand of the patient. For example, base 12 may beconfigured to support the hand of the patient, position the hand of thepatient in the predetermined configuration, limit the movement of one ormore portions of the hand or the wrist relative to base 12, orcombinations thereof, when the hand is positioned over first majorsurface 20.

Second major surface 22 faces away from the hand of the patient when thepalmar dorsal surface of the hand is facing first major surface 20. Insome examples, second major surface 22 is configured to engage with oneor more structures to limit mobility the hand of the patient when tissuecompression device 10 is retained on the hand of the patient. Forexample, second major surface 22 may include bands, clips, straps, orthe like configured to engage with a portion of an operating table orother device in a surgical suite to limit mobility the hand of thepatient when retained in tissue compression device 10. By engaging withone or more structures to limit mobility the hand of the patient, tissuecompression device 10 may enable a clinician to position the hand of thepatient to present the radial artery and/or the ulnar artery moreprominently and improve accuracy of the arteriotomy of the radialartery. In examples in which base 12 is ambidextrous, both first majorsurface 20 and second major surface 22 may be configured to both facethe palmar surface of the hand of the patient or face away from the handof the patient such that base 12 may be inverted to fit either the lefthand or the right hand.

In some examples, base 12 may include a pad disposed on first majorsurface 20. The pad may be configured to engage with a dorsal surface ofthe hand of the patient when the hand is positioned over first majorsurface 20 to improve patient comfort. Additionally, or alternatively,the pad may be configured to position the hand of the patient in apredetermined configuration, as discussed above. For example, the padmay be positioned on base 12 and/or shaped to engage, for example, aportion of the wrist of the patient or the knuckles of the hand toposition the hand in the predetermined configuration. In some examples,the pad is formed from a softer, more pliable material than base 12. Forexample, the pad may include any suitable material, such as silicone,rubber, polyethylene, or a thermoplastic or thermoset plastic, asdiscussed above.

In some examples, the pad may include an inflatable balloon configuredto adjustably control the size and/or rigidity of the pad. Adjustablecontrol of the size and/or rigidity of the pad may enable tissuecompression device 10 to accommodate different hand sizes or shapes andadjust the extent to which the pad extends from first major surface 20to position the hand in the predetermined configuration. The pad may beintegrally formed with base 12 or mechanically connected to base 12 by,for example, an adhesive, a hook-and-loop fastener, or any othersuitable fastener or combination of fasteners.

In some examples, base 12 includes a coating or other material appliedto first major surface 20 (and second major surface 22 in some examples)to increase the static friction between the hand of the patient and base12, which may reduce any undesirable relative movement between the handand base 12.

Flexible backing 14, together with base 12, is also configured to helpreduce any undesirable relative movement between the hand of the patientand base 12, such as ulnar abduction, radial abduction, palmar flexion,and dorsal flexion of the hand. Control of at least one of ulnarabduction, radial abduction, palmar flexion, and dorsal flexion of thehand using flexible backing 14 may improve positioning the hand of thepatient in the predetermined configuration and/or may help constrain thehand during a medical procedure, e.g., without requiring the hand to betaped to a surface on a bed or the like.

Base 12 includes a plurality of base attachment structures 24A and 24B(collectively, “base attachment structures 24”). Base attachmentstructures 24 are configured to mechanically connect flexible backing 14to base 12. In some examples, base attachment structures 24 may bedefined by first major surface 20. For example, first major surface 20may define slots 26A and 26B (collectively, “slots 26”). In otherexamples, base attachment structures 24 may include one or morestructures that extend from base 12. In some examples in which baseattachment structures 24 extend from base 12, base attachment structures24 may be continuous with (e.g., integrally formed with) the part ofbase 12 defining first major surface 20 or physically separate from andmechanically connected to the part of base 12 defining first majorsurface 20 by, for example, welding, an adhesive, or any other suitablefastener. In an “at rest” state in which no external forces (other thannaturally occurring forces) are applied to base attachment structures24, base attachment structures 24 may extend away from first majorsurface 20 in any suitable direction, such as parallel to or transverseto first major surface 20.

Although two base attachment structures 24 (in the form of slots 26) areshown in FIGS. 1A and 1B, in other examples, base 12 may include agreater number of base attachment structures (e.g., more than two baseattachment structures). Base attachment structures 24 may be configuredto mechanically connect flexible backing 14 to base 12. In otherexamples, base attachment structures 24 may be configured to enableflexible backing 14 to be attached to both first major surface 20 andsecond major surface 22, such as in examples in which base 12 may beshaped to engage both the left hand of the patient and the right hand ofthe patient by inverting base 12 to engage the dorsal surface of thehand of the patient with one of the first major surface 20 or secondmajor surface 22.

By mechanically connecting flexible backing 14 to base 12, tissuecompression device 10 may better engage the hand of the patient. Forexample, base attachment structures 24 may enable flexible backing 14 tobe tightened on to the hand of the patient prior to or after inflatingexpandable member 16. Tightening flexible backing 14 to the hand of thepatient prior to or after inflating expandable member 16 may maintain aposition of expandable member 16 over the ulnar region of the patientwhile expandable member 16 is inflated. Maintaining the position ofexpandable member 16 over the ulnar region may more accurately directpressure to selected tissue near the ulnar artery, the ulnar vein, orboth to reduce the amount of pressure to achieve at least partialcompression of the ulnar artery, the ulnar vein, or both. Additionally,or alternatively, tightening flexible backing 14 to the hand of thepatient prior to or after inflating expandable member 16 may providepre-compression of selected tissue at the ulnar region to reduce theamount of pressure exerted by expandable member 16 to achieve at leastpartial compression of the ulnar artery, the ulnar vein, or both.

Flexible backing 14 may be directly or indirectly mechanically connectedto base attachment structures 24 using any suitable technique. Whenconnected, base 12 and flexible backing 14 may define a regionconfigured to receive the hand of the patient. For example, the hand ofthe patient may be inserted or removed from the region defined by (e.g.,between) the base 12 and flexible backing 14 when flexible backing 14 isconnected to base attachment structures 24, or the hand of the patientmay be placed on base 12 before flexible backing 14 is fully connectedto base attachment structures 24. In some examples, base attachmentstructures 24 may be configured to receive flexible backing 14. Forexample, slots 26 may enable the respective attachment structure of baseattachment structures 24 to adjustably mechanically connect flexiblebacking 14 to base 12. For example, flexible backing 14 may include ahook-and-loop fastener on two portions of flexible backing 14 such thata first portion of the hook-and-loop fastener may extend through anaperture defined by slots 26 to attach to a second portion of thehook-and-loop fastener. In other examples, flexible backing 14 mayinclude a mechanical coupling, such as, for example, a clip, configuredto mechanically connect to at least a portion of slots 26.

In some examples, in addition to or instead of base attachmentstructures 24, another part of base 12 may define one or more baseattachment structures configured to receive flexible backing 14 andsecure flexible backing relative to base 12. For example, first majorsurface 20 may define two or more slots defining, for example, a laddertension lock, a triglide slide, or the like. In other examples, baseattachment structures 24 may include any suitable attachment deviceconfigured to secure at least a portion of flexible backing 14 to base12, such as belts, buckle, buttons, or the like.

Flexible backing 14 is configured to engage the hand of a patient whentissue compression device 10 is retained on the hand to urge the handtoward first major surface 20, e.g., to hold the hand of the patient ina predetermined configuration, and to bring expandable member 16 intoengagement with selected tissue a the ulnar region of the patient. Inthe example shown in FIG. 1A, flexible backing 14 defines a first majorsurface 30 (not visible in FIG. 1A, shown in FIG. 3) and second majorsurface 32 and includes a plurality of backing attachment structures 34Aand 34B (collectively, “backing attachment structures 34”).

Flexible backing 14 may include any suitable shape to engage with atleast a portion of the hand of the patient. For example, first majorsurface 30 and second major surface 32 of flexible backing 14 may have ashape corresponds to the anatomical shape of the palmar surface of thehand of a patient to engage with the palmar surface of a hand of apatient. Flexible backing 14 may be shaped to engage with a right handof the patient, a left hand of the patient, or both the left and theright hand of the patient, e.g., flexible backing 14 may beambidextrous. In some examples, flexible backing 14 may at leastpartially conform to a shape of a palmar surface, radial border (FIG.2), and/or ulnar border (FIG. 2) of the hand of the patient when adorsal surface of the hand is engaged with first major surface 20 ofbase 12. By at least partially conforming to the hand of the patient,flexible backing 14 may allow tissue compression device 10 to engage thehand of the patient to position the hand in the predeterminedconfiguration, as discussed above.

In some example, flexible backing 14 includes a substantiallyinextensible material. A substantially inextensible material may includea material that breaks after being extended between about 10% and about100% (as measured in accordance with ASTM Standard D638), with a tensilestrength between about 20 megapascals (MPa) and about 50 MPa (asmeasured in accordance with ASTM Standard D412), and/or with an elasticmodulus between about 0.1 GPa and about 1 GPa (as measured in accordancewith ASTM Standard E2769). For example, when tissue compression device10 is retained on the hand of the patient, increasing pressure inexpandable member 16 (e.g., inflating expandable member 16) results inincreasing pressure on tissue at the ulnar region of the patient, ratherthan resulting in elongation or stretching of flexible backing 14. Inthis way, flexible backing 14 may conform to a palmar surface of thehand of the patient, and reduce elongation or stretching of flexiblebacking 14 when expandable member 16 is inflated.

First major surface 30 of backing 14 is configured to face a palmarsurface of the hand of the patient when tissue compression device 10 isretained on the hand of the patient such that a dorsal surface of thehand faces base 12. That is, the hand of the patient may be positionedbetween first major surface 30 of backing 14 and first major surface 20of base 12. In some examples, first major surface 30 may be configuredto engage with a palmar surface of the hand of the patient. For example,flexible backing 14 may be configured to contact the palmar surface andurge the hand of the patient toward base 12 to position the hand of thepatient in the predetermined configuration when flexible backing 14 istightened via base attachment structures 24 and backing attachmentstructures 34.

Second major surface 32 of flexible backing 14 is configured to faceaway from the hand of the patient when tissue compression device 10 isretained on the hand of the patient such that a dorsal surface of thehand faces base 12. In examples in which flexible backing 14 isambidextrous, first major surface 30 and second major surface 32 may beconfigured to both face the palmar surface of the hand of the patientand face away from the hand of the patient, such that flexible backing14 may be inverted to fit either the left or right hand.

As illustrated in FIG. 1A, flexible backing 14 includes backingattachment structures 34. Each respective backing attachment structureof backing attachment structures 34 may be configured to adjustablysecure flexible backing 14 to a respective attachment structure of baseattachment structures 24. For example, backing attachment structure 34Aincludes a clip configured to mechanically connect flexible backing 14to base attachment structure 24A that defines slot 26A. Similarly,respective backing attachment structures 34B includes a clip configuredto mechanically connect flexible backing 14 to base attachmentstructures 24B that defines slot 26B. In other examples, respectivebacking attachment structures 34 may include any suitable correspondingstructure configured to mechanically connect to respective baseattachment structures 24. In some examples, one or more backingattachment structures of backing attachment structures 34 may enableflexible backing 14 to be tightened on to the hand of the patient priorto or after inflating expandable member 16. In this way, flexiblebacking 14 may allow tissue compression device 10 to engage the hand ofthe patient to position the hand of the patient in the predeterminedconfiguration.

In some examples, backing attachment structures 34 and base attachmentstructures 24 are positioned on flexible backing 14 and base 12,respectively, to provide substantially uniform distribution of forcefrom flexible backing 14 to the hand of the patient when tissuecompression device 10 is retained on the hand of the patient. Forexample, when tissue compression device 10 is retained on the hand ofthe patient such that the palmar surface faces base 12 and aftertightening flexible backing 14 using backing attachment structures 34and base attachment structures 24, flexible backing 14 may provide asubstantially uniform compressive force to at least a portion of thepalmar surface of the hand of the patient. Substantially uniformdistribution of force from flexible backing 14 to the hand of thepatient may improve patient comfort, enable expandable member 16 toprovide a substantially uniform compressive force to selected tissue atthe ulnar region of the patient, or both.

Expandable member 16 is configured to be positioned over the ulnarregion of the patient when tissue compression device 10 is retained onthe hand such that the dorsal surface of the hand faces base 12. Forexample, expandable member 16 may be secured in place to flexiblebacking 14 at a location that positions expandable member over the ulnarregion when tissue compression device 10 is retained on the hand of thepatient such that the dorsal surface of the hand faces base 12. In someexamples, expandable member 16 may be removably secured to flexiblebacking 14 such that a clinician may adjust the position of expandablemember 16 relative to flexible backing 14 prior to retaining tissuecompression device 10 on that hand of the patient. For example,expandable member 16 may be connected to backing 14 via an adhesive,such as a pressure-sensitive adhesive or a removable adhesive, or amechanical fastener, such as a hook-and-loop mechanism, and a clinicianmay detach expandable member 16 from backing 14 by pulling expandablemember 16 away from backing 14 and then subsequently use the adhesive orhook-and-loop mechanism to reattach expandable member 16 to backing 14at a different location.

In addition to or instead of the adhesive or a hook-and-loop mechanism,in some examples, backing attachment structures 34 may be configured toadjust the position of expandable member 16 relative to the hand of thepatient when tissue compression device 10 is retained on the hand of thepatient to position expandable member 16 over the ulnar region. Forexample, a clinician may adjust one or more backing attachmentstructures 34 to move the position of expandable member 16 relative tothe hand of the patient and position expandable member 16 over the ulnarregion.

Expandable member 16 may be mechanically connected to flexible backing14 by any suitable means, such as, for example, an adhesive, thermalbonding, welding, or a mechanical fastener, e.g., by a hook-and-loopfastener. In other examples, expandable member 16 may be integrallyformed with flexible backing 14, such that a position of expandablemember 16 is fixed relative to flexible backing 14. For example,flexible backing 14 may include two or more layers forming a pocket anddefining expandable member 16.

In some examples, flexible backing 14 and/or expandable member 16includes a transparent material, such as polypropylene. A transparentflexible backing 14 and/or expandable member 16 may enable a clinicianto visualize an access site while tissue compression device 10 isretained on the hand of the patient. In contrast, if flexible backing 14and/or expandable member 16 was opaque, the clinician would not be ableto view the access site. By visualizing the access site, the clinicianmay visually confirm patent hemostasis.

Expandable member 16 is configured to apply pressure to selected tissueat the ulnar region when tissue compression device 10 is retained on thehand of the patient (such that the dorsal surface faces base 12) to helpreduce incidence of radial artery occlusion after percutaneous coronaryprocedures with transradial access. Expandable member 16 may define anysuitable shape having any suitable surface area to apply pressure toselected tissue at the ulnar region. For example, a major surface ofexpandable member 16 configured to engage with selected tissue at theulnar region of a patient while the palmar surface of the hand rests onbase 12 may define a triangular shape. In other examples, this surfaceof expandable member 16 may define other geometric shapes, such as anellipse, a quadrilateral or other polygon, or irregular shapes.Additionally, expandable member 16 define any suitable volume to achievea selected pressure on the selected tissue at the ulnar region. Forexample, expandable member 16, when in a deflated configuration or aninflated configuration, may extend any suitable distance from firstmajor surface 30 of flexible backing 14.

Expandable member 16 may include a bladder 36 fluidically connected to achannel 38. Channel 38 may be fluidically connected to one or moreinflation devices 37 configured to inflate bladder 36 and one or moredeflation devices 39 configured to deflate bladder 36. For example,inflation device 37 may include a pump configured to controllablyinflate bladder 36 of expandable member 16 or a syringe configured tocontrollably inflate bladder 36.

Deflation device 39 may include a release valve configured to deflatebladder 36. In some examples, a clinician may use deflation device 39 touncontrollably and fully deflate bladder 36, e.g., prior to removingtissue compression device 10 from the hand of the patient. In otherexamples, deflation device 39 may more controllably deflate bladder 36to compress of the ulnar region. For example, a clinician may inflatebladder 36 using inflation device 37 to a first pressure that is greaterthan a minimum pressure to achieve the desired compression of the ulnarregion, e.g., the clinician may inflate bladder 36 until the clinicianobserves at least partial occlusion of the ulnar artery distal tobladder 36 or ulnar vein proximal to bladder 36 by, for example,palpitation, ultrasonography, pulse-oximetry, or modified Allen's test(e.g., the hand of the patient may be elevated, the hand may be clenchedin a first for about 30 seconds, pressure may be applied over the ulnarartery and the radial artery so as to occlude both arteries while thehand is clenched in the fist, the elevated hand may be subsequentlyunclenched, the color of the hand may be observed as blanched or pallormay be observed at the finger nails, ulnar artery pressure may bereleased while radial artery pressure is maintained, and the time forcolor to return to the hand is observed).

After inflating bladder 36 to the first pressure, the clinician maycontrollably deflate bladder 36 using deflation device 39 to a secondpressure slightly less than the minimum pressure to achieve occlusion ofthe ulnar artery, e.g., the clinician may deflate bladder 36 until theclinician observe return ulnar artery blood flow. After deflatingbladder 36 to the second pressure, the clinician may inflate bladder 36by a predetermined volume, such as, for example, 1 cubic centimeter to20 cubic centimeters of air, to a third pressure and confirm at leastpartial occlusion of the ulnar artery. By controllably deflating bladder36 to the second pressure, the clinician may more accurately inflatebladder 36 to the third pressure using the predetermined volume tosufficiently compress the ulnar region to increase blood flow or bloodpressure in the radial artery.

Bladder 36 may define a first major surface facing base 12 andconfigured to inflate to at least a pressure that provides at leastpartial occlusion of the ulnar artery. In some examples, inflation ofbladder 36 will tend to move the first major surface of bladder 36 awayfrom first major surface 30 of flexible backing 14 and toward firstmajor surface 20 of base 12. When tissue compression device 10 isretained on a hand of the patient, inflation of bladder 36 forces thefirst major surface of bladder 36 against the tissue at the ulnar arteryto provide compression of selected tissue in contact with the firstmajor surface of bladder 36. In this way, expandable member 16 mayinflate to apply a selected pressure to tissue at the ulnar region.

FIG. 2 is a conceptual perspective view illustrating an example tissuecompression device 10 retained on hand 50 of a patient. To improve theclarity of FIG. 2, slots 26, backing attachment structures 34, andsecond lip 17 are not shown. As discussed above, tissue compressiondevice 10 is configured to engage hand 50 to compress selected tissue 52at the ulnar region of the patient. Base 12 is shaped to engage hand 50.For example, first major surface 20 of base 12 is shaped and sized tosupport at least a portion of the wrist of the patient and at least aportion of the dorsal surface of hand 50 including digits of hand 50. Insome examples, first major surface 20 of base 12 is shaped and sized toengage at least part of a forearm of the patient, proximal to the wrist.Additionally, as discussed above with respect to FIGS. 1A and 1B, firstlip 15 is configured to engage an ulnar border 54 of hand 50 (includinga portion of the wrist and/or the forearm) and second lip 17 isconfigured to engage a radial border 56 of hand 50. In some examples,second lip 17 may engage a radial border of a portion of the wristand/or the forearm of the patient.

FIGS. 3A and 3B are conceptual side views in the Y-Z and X-Z planes,respectively, illustrating the example tissue compression device 10 ofFIG. 1A. As illustrated in FIG. 3A, in some examples, first and secondmajor surfaces 20, 22 of base 12 are substantially flat such that firstmajor surface 20, extending along the Y-axis from radial side 21 to anulnar side 19, is substantially planar (e.g., planar or nearly planar tothe extent permitted by manufacturing and material tolerances). In otherexamples, first major surface 20 extending along the Y-axis may becurved, for example, to mimic the anatomical contour of the wrist and/orhand of the patient.

As illustrated in FIG. 3B, in some examples, first and second majorsurfaces 20, 22 of base 12 may include a deflection 33. For example, aproximal portion of base 12 (e.g., extending from proximal end 25 todeflection 33) may extend substantially parallel to the X-axis, whiledistal portion of base 12 (e.g., extending from deflection 33 to distalend 23) extends at an angle relative to the X-axis. Deflection 33 mayinclude any suitable angle, such as an angle between about 0° and about90° relative to the X-axis. Deflection 33 may be positioned at the wristof the patient. By positioning deflection 33 at the wrist, device 10 maybe configured to hold a hand of a patient in a predeterminedconfiguration of the hand of the patient in which there is a dorsalflexion (e.g., extension) of the wrist. Dorsal flexion of the wrist maypresent the radial artery or the ulnar artery more prominently, asdiscussed above.

As discussed above, base 12 may include first lip 15 and/or second lip17, which are configured to help hold the hand of the patient in aparticular configuration when the dorsal surface of the hand is engagedwith first major surface 20 of base 12. In some examples, base 12 maynot include one or both of first lip 15 and second lip 17. First lip 15and second lip 17 may be continuous with (e.g., integrally formed with)base 12 or physically separate from and mechanically connected to thepart of base 12 defining first major surface 20 by, for example,welding, an adhesive, or any other suitable fastener. In an “at rest”state in which no external forces (other than naturally occurringforces) are applied to first lip 15 and second lip 17 may extend awayfrom first major surface 20 in any suitable direction. First lip 15 andsecond lip 17 may include a substantially rigid material, e.g., asdiscussed above in reference to base 12, or may include a flexiblematerial or one or more flexible regions or joints (e.g., areas ofthinner material relative to other portions of the respective lip),which allow the respective lip to deflect, for example, when the hand,the wrist, or the forearm of the patient is received by tissuecompression device 10.

In some examples, first lip 15 and second lip 17 may includesubstantially similar shapes configured to engage both an ulnar side anda radial ride of at least one of the hand, the wrist, or the forearm ofthe patient. In other examples, first lip 15 and second lip 17 mayinclude dissimilar shapes, such that one of first lip 15 or second lip17 is configured to engage an ulnar side of at least one of the hand,the wrist, or the forearm of the patient, and the other of first lip 15and second lip 17 is configured to engage a radial ride of at least oneof the hand, the wrist, or the forearm of the patient.

As illustrated in FIG. 3A, first lip 15 may extend from first majorsurface 20 between about ¼ of an inch (about 0.635 centimeters (cm)) toabout 1 inch (about 2.54 cm), such as about ¼ of an inch, in an X-axisdirection, which is a direction substantially perpendicular (e.g.,perpendicular or nearly perpendicular to the extent permitted bymanufacturing tolerances) to first major surface 20. In other examples,first lip 15 may extend any suitable distance from first major surface20 at any suitable angle relative to first major surface 20 to engage atleast a portion of the ulnar border of the hand of the patient when thedorsal surface of the hand is engaged with first major surface 20. Firstlip 15 may be shaped to mimic the contour of the ulnar side of at leastone of the hand, the wrist, or the forearm of the patient. For example,first lip 15 may include a concave surface shaped to receive at least aportion of the ulnar side of at least one of the hand, the wrist, or theforearm of the patient. In other examples, first lip 15 may includeother shapes, such as a rectangle.

As illustrated in FIG. 3A, second lip 17 may extend from first majorsurface 20 between about ¼ of an inch (about 0.635 centimeters (cm)) toabout 1 inch (about 2.54 cm), such as about ½ of an inch (about 1.27cm), in an X-axis direction substantially perpendicular to first majorsurface 20. In other examples, second lip 17 may extend any suitabledistance from first major surface 20 at any suitable angle relative tofirst major surface 20 to engage at least a portion of the radial borderof the hand of the patient when the dorsal surface of the hand isengaged with first major surface 20. Second lip 17 may be shaped toengage the contour of the radial side of at least one of the hand, thewrist, or the forearm of the patient. For example, second lip 17 mayinclude a protrusion 27 extending substantially perpendicular to aplanar surface 35 of lip 17. When a dorsal surface of the hand of thepatient is positioned over major surface 20, protrusion 27 may extendover at least a portion of the palmar surface of the hand of the patientto, for example, reduce flexion of the wrist of the patient. In otherexamples, second lip 17 may include other cross-sectional shapes, suchas a rectangle, relative to the Y-Z plane.

As discussed above, base attachment structures 24 may be configured tomechanically connect flexible backing 14 to base 12. For example, asshown in FIG. 3A, flexible backing 14 may extend over base 12 to definea region 41 between first major surface 30 of flexible backing andsecond major surface 20 of base 12 that is configured receive the hand,the wrist, and/or the forearm of the patient. In some examples, flexiblebacking 14 may extend over first lip 15 and second lip 17 to secondmajor surface 22 of base 12, such as the backing 14 is on both sides offirst major surface 20. In other examples, flexible backing 14 may beentirely on one side of first major surface 20. An ulnar side 29 offlexible backing 14 may mechanically couple to slot 26A defined by base12. Similarly, a radial side 31 of flexible backing 14 may mechanicallycouple to slot 26B defined by base 12. The mechanical coupling mayinclude any suitable adjustable mechanical coupling, releasablemechanical coupling, fixed mechanical coupling, or combinations thereofincluding, but not limited to, ladder tension lock, triglide slide,belt, buckle, button, clip, or the like. In examples in which ulnar side29 or radial side 31 of flexible backing 14 is adjustably mechanicallycoupled to a respective base attachment structure 24, a position ofexpandable member 16 relative to the hand, the wrist, or the forearm ofthe patient may be adjusted to position expandable member 16 over anulnar region of the patient.

In some examples, bladder 36 of expandable member 16 defines a firstmajor surface 40 facing base 12. Inflation of bladder 36 will tend tomove first major surface 40 of bladder 36 away from first major surface30 of flexible backing 14 and toward first major surface 20 of base 12.When tissue compression device 10 is retained on a hand of the patientsuch that the dorsal surface of the hand faces first major surface 20 ofbase 12, inflation of bladder 36 forces first major surface 40 ofbladder 36 against the tissue at the ulnar region to provide compressionof selected tissue in contact with first major surface 40 of bladder 36.In this way, tissue compression device may compress selected tissue atthe ulnar region of the patient to compress the ulnar artery, the ulnarvein, or both. As discussed above, major surface 40 of expandable member16 may define any suitable shape (e.g., a triangle, pentagon, a circle,an octagon, and the like) configured to engage with the selected tissueregion of patient.

In some examples, tissue compression device 10 is configured to applypressure to both the ulnar region and a radial region including tissuenear a radial artery of the patient. For example, after a transradialpercutaneous coronary procedure, a clinician may use tissue compressiondevice 10 to apply pressure to tissue at the radial artery access siteto achieve patent hemostasis at the access site. FIG. 4 is a conceptualperspective view illustrating an example tissue compression device 10including a second expandable member 58 mechanically connected toflexible backing 14. Second expandable member 58 may be substantiallysimilar to expandable member 16, as discussed above, but is configuredto be positioned over a radial region of the patient, such as atransradial access site, of the patient when the palmar surface of thehand is engaged with flexible backing 14 and the dorsal surface of thehand is engaged with base 12.

Second expandable member 58 may be positioned on flexible backing 14relative to expandable member 16 such that second expandable member 58may be positioned over the radial region when expandable member 16 ispositioned over the ulnar region. In some examples, second expandablemember 58 may be removably secured to flexible backing 14 such that aclinician may adjust the position of second expandable member 58relative to flexible backing 14 prior to retaining tissue compressiondevice 10 on that hand of the patient. For example, second expandablemember 58 may be connected to backing 14 via an adhesive, such as apressure-sensitive adhesive or a removable adhesive, or a mechanicalfastener, such as a hook-and-loop mechanism. The clinician may detachsecond expandable member 58 from flexible backing 14 by pulling secondexpandable member 58 away from flexible backing 14 and then subsequentlyuse the adhesive or hook-and-loop mechanism to reattach secondexpandable member 58 to flexible backing 14 at a different location.

In addition to or instead of the adhesive or a hook-and-loop mechanism,in some examples, backing attachment structures 34 may be configured toadjust the position of second expandable member 58 relative to the handof the patient when tissue compression device 10 is retained on the handof the patient to position second expandable member 58 over the radialregion. For example, a clinician may adjust one or more backingattachment structures 34 to move the position of second expandablemember 58 relative to the hand of the patient and position secondexpandable member 58 over the radial region.

Second expandable member 58 may be mechanically connected to flexiblebacking 14 by any suitable means, such as, for example, an adhesive,thermal bonding, welding, or a mechanical fastener, e.g., by ahook-and-loop fastener. In other examples, second expandable member 58may be integrally formed with flexible backing 14. For example, flexiblebacking 14 may include two or more layers forming a pocket and definingsecond expandable member 58.

In some examples, second expandable member 58 includes a transparentmaterial, such as polypropylene. A transparent second expandable member58 may enable a clinician to visualize an access site at the radialartery while tissue compression device 10 is retained on the hand of thepatient. In contrast, if second expandable member 58 was opaque, theclinician would not be able to view the access site. By visualizing theaccess site, the clinician may visually confirm patent hemostasis.

Second expandable member 58 is configured to apply pressure to theradial region, e.g., transradial access site, when a dorsal surface ofthe hand of the patient is engaged with first major surface 20 of base12. In some examples, positioning the hand of the patient in apredetermined configuration, such as in a dorsal flexion position asdiscuss above in reference to FIG. 3B, may present the radial arterymore prominently to reduce the amount (e.g., duration or pressure) ofradial compression required to achieve hemostasis of the radial arteryafter a percutaneous transradial procedure. Application of pressure tothe radial region, e.g., a transradial access site, may be used to causepatent hemostasis of the access site after a percutaneous transradialcoronary procedure. Second expandable member 58 define any suitable sizeand shape having any suitable surface area to apply pressure to selectedtissue at the radial region. For example, second expandable member 58may have a size and shape that are substantially similar to the size andshape of expandable member 16 as discussed above. Additionally, secondexpandable member 58 define any suitable volume to achieve a selectedpressure on the selected tissue at the radial region. For example,second expandable member 58, when in a deflated configuration or aninflated configuration, may extend any suitable distance from firstmajor surface 30 of flexible backing 14.

Similar to expandable member 16, second expandable member 58 includes abladder 60 fluidically connected to channel 62 that may be connected toone or more inflation devices 66 configured to inflate bladder 60 andone or more deflation devices 64 configured to controllably oruncontrollably deflate bladder 60. In some examples, a clinician mayinflate bladder 60 using inflation device 66 to a first pressure that isgreater than a minimum pressure to achieve patent hemostasis of atransradial access site, e.g., the clinician may inflate bladder 60until the clinician visually confirms stoppage of blood flow from theaccess site. After inflating bladder 60 to the first pressure, theclinician may controllably deflate bladder 60 using deflation device 64to a second pressure slightly less than the minimum pressure to achievepatent hemostasis, e.g., the clinician may deflate bladder 60 until theclinician visually confirms return blood flow from the access site.After deflating bladder 60 to the second pressure, the clinician mayinflate bladder 60 by a predetermined volume, such as, for example, 1cubic centimeter to 20 cubic centimeters of air, to a third pressure andconfirm stoppage of blood flow. In some examples, the third pressure maybe sufficient to achieve patent hemostasis of the transradial accesssite, while preventing occlusion of the radial artery. As discussedabove, concurrent compression of the ulnar region also may reduceocclusion of the radial artery by increasing blood flow and/or bloodpressure in the radial artery. In this way, the expandable member 16 andthe second expandable member 58 may be used together to enable apressure at the transradial access site via second expandable member 58sufficient to achieve hemostasis at the transradial access site withoutcausing radial artery occlusion.

Bladder 60 may define a first major surface facing base 12 and isconfigured to inflate to at least a pressure that provides patenthemostasis of vasculature at the transradial access site. In someexamples, inflation of bladder 60 will tend to move the first majorsurface of bladder 60 away from first major surface 30 of flexiblebacking 14 and toward first major surface 20 of base 12. When tissuecompression device 10 is retained on a hand of the patient, inflation ofbladder 60 forces the first major surface of bladder 60 against thetissue at the transradial access site to provide compression of selectedtissue in contact with the first major surface of bladder 60.

In some examples, a tissue compression device that includes twoexpandable members may have a band-type (e.g., a bracelet) configurationthat is configured to engage less (if any) of a dorsal surface of a handof a patient than tissue compression device 10. FIGS. 5A and 5B areconceptual plan and side views illustrating an example band-type tissuecompression device 70, which includes a band 73, a first expandablemember 76 mechanically connected to band 73, a second expandable member78 mechanically connected to band 73. Tissue compression device 70 isconfigured to apply pressure to selected tissue at an ulnar region and aradial region of the wrist of arm 71 of the patient to thereby compresstissue near the ulnar artery and/or ulnar vein and the radial artery.Tissue compression device 70 may be configured to simultaneously applypressure to selected tissue at the ulnar region and the radial region,and, in some examples, a clinician may separately control the pressuresapplied to the ulnar region and to the radial region via respective andseparate expandable members 76 and 78. Tissue compression device 70 maybe substantially similar to tissue compression device 10, except for thedifferences described herein.

Band 73 is configured to engage the wrist of the patient. For example,band 73 may be shaped to surround at least a portion of the wrist of thepatient. In some examples, band 73 may be shaped to conform to ananatomical shape of a left wrist of the patient, a right wrist of thepatient, or both the left wrist and the right wrist of the patient. Band73 may be adjustable, such that a tension of band 73 on the wrist of thepatient may be adjusted to urge at least one of first expandable member76 or second expandable member 78 toward the wrist of the patient (e.g.,the ulnar region and the radial region, respectively) when the wrist ofthe patient is engaged with the band. In some examples, band 73 mayinclude base 72 and flexible backing 74. Base 72 and flexible backing 74may be formed from materials similar to those discussed above withrespect to base 12 and flexible backing 14. In other examples, however,base 12 and flexible backing 14 may be formed from the same material ormaterials having substantially similar properties (e.g., similarhardnesses). In some examples, base 72 and flexible backing 74 may bephysically separate components mechanically connected to form band 73.In some examples, base 72 and flexible backing 74 may be integrallyformed.

Base 72 defines a first major surface 80 and a second major surface 82on an opposite side of base 72 from first major surface 80, and includesat least one base attachment structure 84A and 84B (“base attachmentstructures 84”). Although two base attachment structures 84 are shown inFIGS. 5A and 5B, in other examples, base 72 may only include one baseattachment structure with which flexible backing 74 may attach to base72. In addition, as discussed above, in some examples, base 72 andflexible backing 74 may be integrally formed, in which case base 72would not define any base attachment structures.

Base 72 may be substantially similar to base 12 described in referenceto FIGS. 1A and 1B, except for the differences described herein. Base 72is configured to engage a left wrist of the patient, a right wrist ofthe patient, or both the left wrist and the right wrist of the patient.For example, base 72 may extend any suitable distance around a wrist ofthe patient. First major surface 80 may include any suitable shape (inthe Y-Z plane shown in FIG. 5B) configured to engage with at least aportion of the wrist of the patient, such as elliptical, rectangular, orirregular shapes. In some examples, base 72 may have a shape in the Y-Zplane that corresponds to an anatomical shape of at least part of awrist of the patient (e.g., mimics the general contour of the wrist orpart of the wrist). Second major surface 82 may be shaped the same as orsubstantially similar to first major surface 80, such that a thicknessof base is substantially uniform from an ulnar side 79 of base 72 to aradial side 81 of base 72. In other examples, second major surface 82may be substantially planar to enable base 72 to engage with a flatsurface, such as an operating table.

Base attachment structures 84 may be substantially similar to baseattachment structures 24 described in reference to FIG. 1A, except forthe differences described herein. For example, base attachmentstructures 84 configured to adjustably mechanically connect flexiblebacking 74 to base 72 to enable flexible backing 74 to be tightened onto the wrist of the patient prior to or after inflating first and secondexpandable members 76 and 78. Tightening flexible backing 74 on to thewrist of the patient may maintain a position of first and secondexpandable members 76 and 78 over the ulnar region and the radial regionof the patient, provide pre-compression of selected tissue at the ulnarregion, the radial region, or both. Maintaining a position of first andsecond expandable members 76 and 78 over the ulnar region and the radialregion of the patient may more accurately direct pressure to achievecompression of the ulnar region and the radial region. Providingpre-compression of selected tissue at the ulnar region and/or the radialregion may reduce the amount of pressure exerted by first expandablemember 76 to achieve compression of the ulnar artery, ulnar vein, orboth, as well as the pressure exerted by second expandable member 78 toachieve patent hemostasis of a transradial access site at the radialregion.

Flexible backing 74 may be substantially similar to flexible backing 14described in reference to FIG. 1A, except for the differences describedherein. Flexible backing 74 is configured to engage a left wrist of thepatient, a right wrist of the patient, or both the left wrist and theright wrist of the patient. For example, flexible backing 74 may definea band having a width (measured along the X-axis) of between about 1inch (2.54 cm) to about 4 inches (10.16 cm) and a length (measuredcircumferentially in the Y-Z plane) sufficient to surround the wrist,such as between about 4 inches (10.16 cm) to about 12 inches (25.4 cm).The cross-sectional shape of flexible backing 14 in the Y-Z plane mayinclude any suitable shape, such as rectangular, elliptical, othergeometry shapes, or irregular shapes. The shape of flexible backing maybe selected to improve patient comfort, reduce movement of flexiblebacking when tissue compression device 70 is retaining on the wrist ofthe patient, or both.

In examples in which flexible backing 74 is separate from and connectedto base 72, flexible backing 74 may include at least one (e.g., one ormore) backing attachment structure 85A and 85B (“backing attachmentstructures 85”). Backing attachment structures 85 may be substantiallysimilar to backing attachment structures 34 described in reference toFIG. 1A, except for the differences described herein. For example,backing attachment structures 85 may be configured to adjustably secureflexible backing 74 to a respective attachment structure of baseattachment structures 84.

First and second expandable members 76 and 78 may be the substantiallysimilar to expandable member 16 describe in reference to FIG. 1A, exceptfor the differences described herein. For example, first expandablemember 76 and second expandable member 78 may be fixed to or adjustablypositioned on band 73 relative to each other to enable first expandablemember 76 to be positioned over the ulnar region of the patient and toenable second expandable member 78 to be positioned over the radialregion of the patient when tissue compression device 70 is retained onthe wrist of the patient. In some examples, first expandable member 76may be mechanically connected to at least one of base 72 or flexiblebacking 74. In some examples, second expandable member 78 may bemechanically connected to at least one of base 72 or flexible backing74. In some examples, first expandable member 76 may include a firstbladder 86 fluidically connected to inflation device 91 and deflationdevice 92 by channel 90. In some examples, second expandable member 78may include a second bladder 88 fluidically connected to inflationdevice 95 and deflation device 96 by channel 94.

In other examples, first expandable member 76 and second expandablemember 78 may be fluidically connected to a common channel including oneor more valves to fluidically isolate first expandable member 76 and/orsecond expandable member 78 from one or more inflation devices and oneor more deflation devices. Inflation devices 91 and 95 may besubstantially the same as inflation devices 37, and deflation devices 92and 96 may be substantially the same as deflation devices 39, describedin reference to FIG. 1A. In some examples, first bladder 86 may beconfigured to inflate to at least a pressure to cause compression oftissue near an ulnar artery of the patient. For example, inflation (or aseries of inflations and deflations) of first bladder 86 may be used tocompress the ulnar region of the patient to increase blood flow or bloodpressure in the radial artery of the patient. In some examples, secondbladder 88 may be configured to inflate to at least a pressure to causepatent hemostasis of a vascular access site at the radial artery of thepatient. For example, inflation (or a series of inflations anddeflations) of second bladder 88 may be used to compress the radialregion of the patient to achieve patent hemostasis of a transradialaccess site at a radial artery of the patient.

The tissue compression devices described herein may be assembled usingany suitable technique. FIG. 6 is a flow diagram illustrating an examplemethod of assembling an example tissue compression device including abase, a flexible backing adjustably mechanically connected to the base,and an expandable member mechanically connected to the flexible backing.The tissue compression device may be the same as or substantiallysimilar to tissue compression device 10 discussed above with respect toFIGS. 1A-5B. Although FIG. 6 is described with respect to tissuecompression device 10, in other examples, the method of FIG. 6 may beused to assemble or use other tissue compression devices, such as tissuecompression device 70, or tissue compression devices including aflexible backing adjustably mechanically connected to a base and anexpandable member mechanically connected to the flexible backing.

In accordance with the method shown in FIG. 6, a user or a devicemechanically connects flexible backing 14 of tissue compression device10 to first base attachment structure 24A of a plurality of baseattachment structures 24 defined by or extending from first majorsurface 20 of base 12 of tissue compression device 10 (102). Forexample, mechanically connecting flexible backing 14 to base 12 mayinclude securing backing attachment structure 34A to slot 26A with aclip or other mechanical fastener. The method also includes mechanicallyconnecting flexible backing 14 to second base attachment structure 24Bof the plurality of base attachment structures 24 (104), such as bysecuring backing attachment structure 34B to slot 26B with a clip orother mechanical fastener. Flexible backing 14 may be mechanicallyconnected to base 12 using the technique shown in FIG. 6 before or afterthe dorsal surface of the hand of the patient is positioned on firstmajor surface 20.

In some examples, after flexible backing 14 is connected to base 12 andwhile the dorsal surface of the hand of the patient is engaged withfirst major surface 20 of base 12, the user may tighten flexible backing14 onto the palmar surface of the hand of the patient in order to bringexpandable member 16 into better engagement with selected tissue of thepatient. For example, the user may pull backing attachment structures34A and 34B further through the respective slots 26A and 26B.

In some examples, the method of FIG. 6 may be part of a method offorming or assembling tissue compression device 10 and may furtherinclude, before mechanically connecting flexible backing 14 to base 12,thermoforming or molding base 12. Base 12 may include a substantiallyrigid thermoplastic configured to be thermoformed to substantiallyconform to an anatomical shape of at least one of the hand, the wrist,or the forearm of the patient or a substantially rigid thermoset plasticconfigured to be molded to substantially conform to an anatomical shapeof at least one of the hand, the wrist, or the forearm of the patient.By thermoforming or molding base 12 to conform to an anatomical shape ofat least one of the hand, the wrist, or the forearm of the patient, base12 may be shaped to improve patient comfort, present the ulnar artery orradial artery more prominently, or both.

In some examples, base 12 is configured to position the hand of thepatient in a predetermined configuration when the dorsal surface of thehand is engaged with first major surface 20 of base 12 using a selectedshape of at least one of first major surface 20, first lip 15, or secondlip 17. In examples in which base 12 includes a pad disposed on base 12,assembling tissue compression device 10 may include positioning the padon base 12 such that the pad is configured to engage at least a portionof the dorsal surface of at least one of the hand, the wrist, or theforearm of the patient to position at least one of the hand, the wrist,or the forearm of the patient of the patient in the predeterminedconfiguration when the dorsal surface of the hand is engaged with firstmajor surface 20 of base 12. In examples in which base 12 includes firstlip 15 and/or second lip 17, assembling tissue compression device 10 mayinclude integrally forming first lip 15 and/or second lip 17 with base12, or forming first lip 15 and/or second lip 17 that is physicallyseparate from base 12 and attaching first lip 15 and/or second lip 17 tobase 12, such that first lip 15 and/or second lip 17 is configured tocontrol at least one of radial abduction, ulnar abduction, palmarflexion, or dorsal flexion of the hand the patient when the dorsalsurface of the hand is engaged with first major surface 20 of base 12 tohelp keep the hand in the predetermined configuration.

As discussed above, base 12 may include at least one base attachmentstructure 24 that is integrally formed with the first major surface 20.In other examples, assembling tissue compression device 10 may includeattaching at least one base attachment structure of the plurality ofbase attachment structures 24 that is physically separate from firstmajor surface 20 to first major surface 20. In some examples, at leastone attachment structure of the plurality of base attachment structuresextend away from the major surface in a direction parallel to and/ortransverse to the major surface.

The tissue compression devices describe herein may be retained on a handof a patient using any suitable technique. FIG. 7 is a flow diagramillustrating an example method of using a tissue compression deviceincluding a base, a flexible backing adjustably mechanically connectedto the base, and an expandable member mechanically connected to theflexible backing to a patient. The tissue compression device may be thesame as or substantially similar to tissue compression device 10discussed above with respect to FIGS. 1A-5B. Although FIG. 7 isdescribed with respect to tissue compression device 10, in otherexamples, the method of FIG. 7 may be used with other tissue compressiondevices, such as tissue compression device 70, or tissue compressiondevices including a flexible backing adjustably mechanically connectedto a base and an expandable member mechanically connected to theflexible backing.

The method shown in FIG. 7 includes positioning a dorsal surface of ahand of a patient over base 12 of tissue compression device 10 (112). Insome examples, the hand of the patient may be positioned over firstmajor surface 20 of base 12 while base 12 and flexible backing 14 aremechanically connected to each other, such as by sliding the handbetween the region defined between base 12 and flexible backing 14 whenflexible backing 14 is connected to base 12. In other examples, the handof the patient may be positioned on first major surface 20 of base 12while flexible backing 14 is mechanically separated from base 12, and,after the hand is positioned on first major surface 20, flexible backing14 may be mechanically connected to base 12.

The method of FIG. 7 also includes positioning expandable member 16 overan ulnar region of the patient (114). In some examples, expandablemember 16 is mechanically connected to flexible backing 14, such thatpositioning expandable member 16 over the ulnar region may includetightening flexible backing 14 over the palmar surface of the hand ofthe patient while the dorsal surface is engaged with first major surface20 of base 12. Depending on the anatomy of the patient, a user may alsoadjust the position of expandable member 16 relative to the hand of thepatient, such as by repositioning flexible backing 14 relative to base12 using the base attachment structure 24 and the backing attachmentstructures 34 (e.g., tightening and loosening as needed to moveexpandable member 16 relative to base 12). In some examples, expandablemember 16 is movable relative to backing 14, and a user may detachexpandable member 16 from backing 14 and then subsequently reattachingexpandable member 16 to backing 14 at a different location, therebyenabling a user to adjust the position of expandable member 16 relativeto base 12 and the hand of the patient.

The method of FIG. 6 also includes inflating expandable member 16 toapply pressure to tissue at the ulnar region (116). For example,expandable member 16 includes bladder 36 such that inflating expandablemember 16 includes inflating bladder 36 to cause compression of tissuenear the ulnar artery. In some examples, base 12 includes asubstantially rigid thermoplastic or a substantially rigid thermosetplastic, and flexible backing 14 includes a substantially inextensiblematerial, such that when tissue compression device 10 is retained on thehand of the patient, the hand is constrained between the substantiallyrigid base 12 and flexible backing 14 and increasing pressure inexpandable member 16 results in increasing pressure on selected tissueat the ulnar region of the patient, rather than resulting in elongationor stretching of flexible backing 14.

In examples in which tissue compression device 10 includes secondexpandable member 58 mechanically connected to flexible backing 14, thetechnique may include, after positioning the dorsal surface of the handof the patient on first major surface 20 of base 12, adjusting aposition of second expandable member 58 to position second expandablemember 58 over a radial artery of the patient, such as, for example,over a transradial access site. The technique also may include, afteradjusting a position of second expandable member 58, inflating secondexpandable member 58 to apply pressure to a radial artery of the patientto cause patent hemostasis of a vascular access site at the radialartery. In some examples, the technique may also include, afterpositioning the dorsal surface of the hand of the patient on first majorsurface 20 of base 20, inflating second expandable member 58 to applypressure to a radial artery of the patient, e.g., to attempt to achieveor to actually achieve patent hemostasis of a vascular access site atthe radial artery.

Various examples have been described. Any combination of the describedsystems, devices, operations, or functions is contemplated. These andother examples are within the scope of the following claims.

What is claimed is:
 1. A tissue compression device comprising: a basecomprising a major surface configured to engage a dorsal surface of ahand of a patient; a flexible backing adjustably mechanically connectedto the base and configured to engage a palmar surface of the hand whenthe dorsal surface of the hand is engaged with the base; and anexpandable member mechanically connected to the flexible backing,wherein the expandable member is configured to be positioned over anulnar region of the patient when the palmar surface of the hand isengaged with the flexible backing and the dorsal surface of the hand isengaged with the base, and wherein the expandable member is configuredto apply pressure to the ulnar region.
 2. The tissue compression deviceof claim 1, wherein the expandable member comprises a bladder configureto inflate to at least a pressure to cause compression of tissue near anulnar artery of the patient.
 3. The tissue compression device of claim1, wherein the base comprises a plurality of base attachment structures,wherein the flexible backing comprises a plurality of backing attachmentstructures, and wherein each backing attachment structure of theplurality of backing attachment structures is configured to adjustablymechanically connect the flexible backing to a respective baseattachment structure of the plurality of base attachment structures. 4.The tissue compression device of claim 3, wherein at least one backingattachment structure of the plurality of backing attachment structuresis configured to adjust a tension of the flexible backing to urge thedorsal surface of the hand of the patient toward the major surface ofthe base when the palmar surface of the hand is engaged with theflexible backing.
 5. The tissue compression device of claim 1, whereinthe expandable member is removably mechanically connected to theflexible backing.
 6. The tissue compression device of claim 1, whereinthe expandable member is integrally formed with the flexible backing. 7.The tissue compression device of claim 1, wherein the flexible backingcomprises a substantially inextensible material.
 8. The tissuecompression device of claim 1, wherein at least one of the base or theflexible backing is configured to engage a left hand of the patient, aright hand of the patient, or both the left hand and the right hand ofthe patient.
 9. The tissue compression device of claim 1, wherein thebase comprises a substantially rigid thermoplastic or a substantiallyrigid thermoset plastic.
 10. The tissue compression device of claim 1,wherein the base is configured to reduce a range of motion of a digit ofthe hand or a portion of a wrist of the patient when the dorsal surfaceof the hand is engaged with the first major surface of the base.
 11. Thetissue compression device of claim 1, wherein the base comprises: afirst lip extending from the major surface and configured to engage anulnar border of the hand when the dorsal surface of the hand is engagedwith the base; and a second lip extending from the major surface andconfigured to engage a radial border of the hand when the dorsal surfaceof the hand is engaged with the base.
 12. The tissue compression deviceof claim 1, wherein the base is configured to position the hand of thepatient in a predetermined configuration when the dorsal surface of thehand is engaged with the major surface of the base.
 13. The tissuecompression device of claim 1, wherein the expandable member comprises afirst expandable member, the tissue compression device furthercomprising a second expandable member mechanically connected to theflexible backing, wherein the second expandable member is configured tobe positioned over a radial artery of the patient when the palmarsurface of the hand is engaged with the flexible backing and the dorsalsurface of the hand is engaged with the base, the second expandablemember being configured to apply pressure to the radial artery.
 14. Thetissue compression device of claim 13, wherein the second expandablemember comprises a bladder configure to inflate to at least a pressureto cause patent hemostasis of a vascular access site at the radialartery of the patient.
 15. A tissue compression device comprising: arigid base comprising: a major surface configured to engage a dorsalsurface of a hand of a patient; a radial lip extending from the majorsurface and configured to engage a radial border of the hand when thedorsal surface of the hand is engaged with the base; and a ulnar lipextending from the major surface and configured to engage an ulnarborder of the hand when the dorsal surface of the hand is engaged withthe base; an inextensible flexible backing adjustably mechanicallyconnected to the base and configured to engage a palmar surface of thehand to urge the dorsal surface of the hand toward the major surface ofthe base; and an expandable member mechanically connected to theflexible backing, wherein the expandable member is configured to bepositioned over an ulnar region of the patient when the palmar surfaceof the hand is engaged with the flexible backing and the dorsal surfaceof the hand is engaged with the base, and wherein the expandable memberis configured to inflate to increase the volume of the expandablemember.
 16. The tissue compression device of claim 15, wherein theexpandable member is configured to be detached and subsequentlyreattached to the flexible backing.
 17. A method comprising:mechanically connecting a flexible backing of a tissue compressiondevice to a first base attachment structure of a plurality of baseattachment structures defined by or extending from a major surface of abase of the tissue compression device, wherein the major surface isconfigured to engage a dorsal surface of a hand of a patient; andmechanically connecting the flexible backing to a second base attachmentstructure of the plurality of base attachment structures, wherein theflexible backing is configured to be adjustably mechanically connectedto the base, wherein the tissue compression device further comprises anexpandable member mechanically connected to the flexible backing,wherein the expandable member is configured to be positioned over anulnar region of the patient when the dorsal surface of the hand isengaged with the major surface of the base, wherein the expandablemember is configured to apply pressure to tissue near an ulnar artery ofthe patient.
 18. The method of claim 17, further comprising positioningthe dorsal surface of the hand of the patient on the major surface ofthe base.
 19. The method of claim 18, further comprising, afterpositioning the dorsal surface of the hand of the patient on the majorsurface of the base, inflating the expandable member to causecompression of tissue near the ulnar artery.
 20. The method of claim 18,further comprising, after positioning the dorsal surface of the hand ofthe patient on the major surface of the base, adjusting a position ofthe expandable member relative to the hand of the patient.
 21. Themethod of claim 20, wherein adjusting the position of the expandablemember relative to the hand of the patient comprises loosening ortightening a mechanical connection between the flexible backing and atleast one of the first or second base attachment structures.
 22. Themethod of claim 20, wherein adjusting the position of the expandablemember relative to the hand of the patient comprises detaching theexpandable member from the flexible backing and subsequently reattachingthe expandable member to the flexible backing.
 23. The method of claim17, wherein the flexible backing comprises a plurality of backingattachment structures, wherein mechanically connecting the flexiblebacking to the first base attachment structure comprises adjustablymechanically connecting a first backing attachment structure of theplurality of backing attachment structures to the first base attachmentstructure, and wherein mechanically connecting the flexible backing tothe second base attachment structure comprises adjustably mechanicallyconnecting a second backing attachment structure of the plurality ofbacking attachment structures to the second base attachment structure.24. The method of claim 17, wherein the expandable member comprises afirst expandable member and the tissue compression device furthercomprises a second expandable member mechanically connected to theflexible backing, and wherein the method further comprises: afterpositioning the dorsal surface of the hand of the patient on the majorsurface of the base, adjusting a position of the second expandablemember to position the second expandable member over a radial artery ofthe patient; and after adjusting a position of the second expandablemember, inflating the second expandable member to apply pressure to aradial artery of the patient to cause patent hemostasis of a vascularaccess site at the radial artery.
 25. A tissue compression devicecomprising: a band configured to engage a wrist of a patient; a firstexpandable member mechanically connected to the band, wherein the firstexpandable member is configured to be positioned over an ulnar region ofthe patient when the band is engaged with the wrist of the patient, thefirst expandable member being configured to apply pressure to the ulnarregion; and a second expandable member mechanically connected to theband, wherein the second expandable member is configured to bepositioned over a radial region of the patient when the band is engagedwith the wrist of the patient, and the second expandable member beingconfigured to apply pressure to the radial region.
 26. The tissuecompression device of claim 25, wherein the first expandable membercomprises a first bladder configured to inflate to at least a pressureto cause compression of tissue near an ulnar artery of the patient, andwherein the second expandable member comprises a second bladderconfigured to inflate to at least a pressure to cause patent hemostasisof a vascular access site at a radial artery of the patient.
 27. Thetissue compression device of claim 25, wherein at least one of the firstexpandable member or the second expandable member is removablymechanically connected to the band.
 28. The tissue compression device ofclaim 25, wherein at least one of the first expandable member or thesecond expandable member is integrally formed with the band.
 29. Thetissue compression device of claim 25, wherein the band comprises: abase comprising a major surface configured to engage a first portion ofthe wrist of the patient; and a flexible backing adjustably mechanicallyconnected to the base and configured to engage a second portion of thewrist of the patient, wherein the first expandable member ismechanically connected to at least one of the base or the flexiblebacking, and wherein the second expandable member is mechanicallyconnected to at least one of the base or the flexible backing.
 30. Thetissue compression device of claim 29, wherein the base comprises atleast one base attachment structure, wherein the flexible backingcomprises at least one backing attachment structure, wherein the atleast one backing attachment structure is configured to adjustablymechanically connect the flexible backing to the at least one baseattachment structure.
 31. The tissue compression device of claim 30,wherein the at least one backing attachment structure is configured toadjust a tension of the flexible backing to urge at least one of thefirst expandable member or the second expandable member toward the wristof the patient when the wrist of the patient is engaged with the band.32. The tissue compression device of claim 29, wherein the basecomprises a substantially rigid thermoplastic or a substantially rigidmaterial and the flexible backing comprises a substantially inextensiblematerial.